Allergic Rhinitis
Conditions
Keywords
Patient preference, Best-Worst Scaling, Treatment attributes
Brief summary
The study seeks to understand patients' satisfaction and importance of treatment attributes for Allergic Rhinitis nasal sprays from two brands (RYALTRIS® vs. DYMISTA®).
Detailed description
The study seeks to understand patients' satisfaction and importance of treatment attributes for Allergic Rhinitis nasal sprays from two brands (RYALTRIS® vs. DYMISTA®). To directly compare patient satisfaction with 2 different Allergic Rhinitis nasal sprays, an observational, cross-sectional study design with 2 independent samples was chosen. Participants will complete an online survey involving a Best-Worst scaling (BWS) task to determine satisfaction and importance index for sensory attributes. The suggested treatment attributes are informed by a range of previous studies, including those conducted by Meltzer et al 2005 and Price et al 2020, and methodology from CaPPRe's own work in developing indices for importance and satisfaction of treatment attributes using BWS.
Interventions
OTHERObservational
In this observational study, participants initated on RYALTRIS/DYMISTA nasal spray will complete a cross-sectional online survey that includes a Best-Worst Scaling task to capture their satisfaction and importance of various treatment attributes.
Sponsors
Seqirus
Glenmark Pharmaceuticals S.A.
Community and Patient Preference Research Pty Ltd
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Allergic Rhinitis patients (moderate-to-severe Seasonal Allergic Rhinitis or Perennial Allergic Rhinitis) with or without conjunctivitis who meet the following criteria will be offered the opportunity to participate in the study: * Patients above 18 years old * Fluent in English * Patients initiated on RYALTRIS® or DYMISTA® nasal spray in the last 12 months and currently using treatment * Willing and able to provide consent to participate
Exclusion criteria
* Have reported a loss of taste and/or smell related to COVID-19 (or other medical condition) * Are employed by a pharmaceutical company (to avoid conflict of interest) * Are employed by a vaccine company (to avoid conflict of interest) * Do not have access to the internet (to ensure validity of the data) * Are unable to read and understand English (to ensure validity of the data)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score) | Cross-sectional - through study completion, an average of 3 months | The primary study endpoint is the overall index score from the Best Worst Scaling exercise, to reflect satisfaction and importance of treatment attributes of the RYALTRIS® and DYMISTA® nasal spray. Index scores from the Best Worst Scaling exercise range from 0 to 100, with higher scores indicating higher satisfaction of treatment attributes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescaled Scores From Best-Worst Scaling Task | Cross-sectional - through study completion, an average of 3 months | Secondary study endpoints were the rescaled Best Worst Scaling domain scores from the Best Worst Scaling exercise (i.e., scores for each of the domains on satisfaction and importance). Rescaled Best-Worst Scaling domain scores range from 0 to 10 and represent the satisfaction and importance of each domain. Higher satisfaction rescaled scores indicate higher satisfaction on a treatment attribute. Higher importance rescaled scores indicate higher importance of the treatment attribute. Higher rescaled satisfaction and importance scores suggest a better outcome since participants are satisfied and more likely to adhere to their current treatment. |
Countries
Australia
Participant flow
Pre-assignment details
As some eligible participants did not complete the online survey, more participants had to be recruited to meet the target sample size. This was done to ensure there was enough statistical power for analyses.
Participants by arm
| Arm | Count |
|---|---|
| Patients on RYALTRIS Patients who are currently using RYALTRIS nasal spray.
Observational: In this observational study, participants initated on RYALTRIS/DYMISTA nasal spray will complete a cross-sectional online survey that includes a Best-Worst Scaling task to capture their satisfaction and importance of various treatment attributes. | 98 |
| Patients on DYMISTA Patients who are currently using DYMISTA nasal spray.
Observational: In this observational study, participants initated on RYALTRIS/DYMISTA nasal spray will complete a cross-sectional online survey that includes a Best-Worst Scaling task to capture their satisfaction and importance of various treatment attributes. | 328 |
| Total | 426 |
Baseline characteristics
| Characteristic | Patients on DYMISTA | Total | Patients on RYALTRIS |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 42 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 292 Participants | 384 Participants | 92 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex/Gender, Customized Gender Female | 249 Participants | 293 Participants | 44 Participants |
| Sex/Gender, Customized Gender Male | 77 Participants | 131 Participants | 54 Participants |
| Sex/Gender, Customized Gender Non-binary/gender fluid | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Gender Prefer not to answer | 1 Participants | 1 Participants | 0 Participants |
| Treatment Satisfaction Index | 62.78 units on a scale ranging from 0 to 100. STANDARD_DEVIATION 12.6 | 64.04 units on a scale ranging from 0 to 100. STANDARD_DEVIATION 13.07 | 68.26 units on a scale ranging from 0 to 100. STANDARD_DEVIATION 13.76 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score)
The primary study endpoint is the overall index score from the Best Worst Scaling exercise, to reflect satisfaction and importance of treatment attributes of the RYALTRIS® and DYMISTA® nasal spray. Index scores from the Best Worst Scaling exercise range from 0 to 100, with higher scores indicating higher satisfaction of treatment attributes.
Time frame: Cross-sectional - through study completion, an average of 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Using Ryaltris (OLO/MOM) | Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score) | 68.26 units on a scale | Standard Error 1.39 |
| Participants Using Dymista (AZE/FLU) | Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score) | 62.78 units on a scale | Standard Error 0.7 |
p-value: <0.001ANOVA
Secondary
Rescaled Scores From Best-Worst Scaling Task
Secondary study endpoints were the rescaled Best Worst Scaling domain scores from the Best Worst Scaling exercise (i.e., scores for each of the domains on satisfaction and importance). Rescaled Best-Worst Scaling domain scores range from 0 to 10 and represent the satisfaction and importance of each domain. Higher satisfaction rescaled scores indicate higher satisfaction on a treatment attribute. Higher importance rescaled scores indicate higher importance of the treatment attribute. Higher rescaled satisfaction and importance scores suggest a better outcome since participants are satisfied and more likely to adhere to their current treatment.
Time frame: Cross-sectional - through study completion, an average of 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Immediate taste of medication | 5.84 units on a scale | Standard Error 0.59 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Dryness of your nose or throat | 6.41 units on a scale | Standard Error 0.65 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Aftertaste of medication | 5.59 units on a scale | Standard Error 0.56 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Smell of medication | 6.31 units on a scale | Standard Error 0.64 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Smell of medication | 5.20 units on a scale | Standard Error 0.53 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Convenience (how easy it is to administer) | 7.31 units on a scale | Standard Error 0.74 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Irritation to your nose | 6.08 units on a scale | Standard Error 0.61 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Urge to sneeze | 6.35 units on a scale | Standard Error 0.64 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Urge to sneeze | 5.88 units on a scale | Standard Error 0.59 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Fast acting (how quickly it works | 7.55 units on a scale | Standard Error 0.76 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Dripping out your nose/down your throat | 6.29 units on a scale | Standard Error 0.64 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Aftertaste of medication | 5.84 units on a scale | Standard Error 0.59 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Dryness of your nose or throat | 6.28 units on a scale | Standard Error 0.63 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Duration of effect (long lasting) | 7.30 units on a scale | Standard Error 0.74 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Convenience (how easy it is to administer) | 6.65 units on a scale | Standard Error 0.67 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Dripping out your nose/down your throat | 6.20 units on a scale | Standard Error 0.63 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Fast acting (how quickly it works) | 7.35 units on a scale | Standard Error 0.74 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Perceived allergic rhinitis symptom control | 7.38 units on a scale | Standard Error 0.75 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Duration of effect (long lasting) | 7.34 units on a scale | Standard Error 0.74 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Irritation to your nose | 6.05 units on a scale | Standard Error 0.61 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Importance - Perceived allergic rhinitis symptom control | 8.00 units on a scale | Standard Error 0.81 |
| Participants Using Ryaltris (OLO/MOM) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Immediate taste of medication | 6.12 units on a scale | Standard Error 0.62 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Perceived allergic rhinitis symptom control | 8.86 units on a scale | Standard Error 0.49 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Immediate taste of medication | 4.66 units on a scale | Standard Error 0.26 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Aftertaste of medication | 4.21 units on a scale | Standard Error 0.23 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Smell of medication | 5.55 units on a scale | Standard Error 0.31 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Irritation to your nose | 5.37 units on a scale | Standard Error 0.3 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Urge to sneeze | 5.52 units on a scale | Standard Error 0.3 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Dripping out your nose/down your throat | 4.89 units on a scale | Standard Error 0.27 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Dryness of your nose or throat | 5.64 units on a scale | Standard Error 0.31 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Convenience (how easy it is to administer) | 7.15 units on a scale | Standard Error 0.39 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Fast acting (how quickly it works | 7.16 units on a scale | Standard Error 0.4 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Duration of effect (long lasting) | 6.89 units on a scale | Standard Error 0.38 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Satisfaction - Perceived allergic rhinitis symptom control | 7.96 units on a scale | Standard Error 0.44 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Immediate taste of medication | 4.63 units on a scale | Standard Error 0.26 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Aftertaste of medication | 4.80 units on a scale | Standard Error 0.27 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Smell of medication | 3.41 units on a scale | Standard Error 0.19 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Irritation to your nose | 5.51 units on a scale | Standard Error 0.3 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Urge to sneeze | 4.69 units on a scale | Standard Error 0.26 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Dripping out your nose/down your throat | 5.43 units on a scale | Standard Error 0.3 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Dryness of your nose or throat | 5.49 units on a scale | Standard Error 0.3 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Convenience (how easy it is to administer) | 6.17 units on a scale | Standard Error 0.34 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Fast acting (how quickly it works) | 7.48 units on a scale | Standard Error 0.41 |
| Participants Using Dymista (AZE/FLU) | Rescaled Scores From Best-Worst Scaling Task | Importance - Duration of effect (long lasting) | 7.70 units on a scale | Standard Error 0.43 |
p-value: <0.001MANOVA